Senior Clinical Project Manager

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee the planning, execution, and successful delivery of assigned global clinical studies.

• Manage timelines, budgets, quality standards, and the overall operational execution of studies.

• Identify and mitigate operational risks and challenges to ensure studies remain on schedule.

• Lead cross-functional study teams, fostering collaboration, accountability, decision-making, and problem-solving.

• Collaborate with Clinical Operations, Data Management, Regulatory Affairs, Clinical Supply, and other departments.

• Supervise CROs and external vendors.

• Evaluate CRO and vendor performance, ensuring alignment with timelines, budgets, quality standards, and contractual obligations.

• Communicate updates on study progress, risks, and significant decisions to internal stakeholders and Clinical Operations leadership.

• Contribute to Clinical Operations processes and methodologies that enhance efficient and high-quality study execution.

• Perform additional duties and responsibilities as assigned.

⛳️ Requirements

• Bachelor’s degree in health science or a related discipline.

• Over 8 years of clinical research experience, with significant responsibilities in managing complex clinical trials.

• Strong experience in global clinical trials and later-stage development, preferably including Phase III.

• Considerable experience leading large, complex Phase II studies will also be taken into account.

• Proven ability to lead and influence cross-functional study teams.

• Practical experience in managing CROs and vendors while proactively addressing operational risks.

• Comprehensive knowledge of GCP, ICH, FDA, and relevant global clinical trial regulations.

• Excellent communication and problem-solving abilities.

• Capacity to work independently, advocate for necessary resources, and identify when to seek support from others.

• Preferred: Experience in Phase III global studies.

• Preferred: Clinical development experience in oncology or rare diseases.

• Preferred: Familiarity with eTMF, EDC, IWRS, and RBQM platforms.

• Preferred: Background in managing clinical study budgets and contracts.

• Preferred: Experience in a fast-paced biotechnology setting.

• Preferred: PMP certification or equivalent project management training.

• Availability for occasional early-morning or evening meetings across different time zones.

• Travel of about 25% may be required, including trips to Boston approximately twice a year and attendance at relevant conferences or study-related meetings.

🏝️ Benefits

• Competitive salary and annual bonus.

• Long-term incentive plan.

• Comprehensive benefits and additional incentive compensation plans (if applicable).

• Medical, dental, and vision insurance.

• 401(k) retirement plan with company matching.

• Generous parental leave policy.

• Family planning benefits.

• Opportunities for personal and professional development.